Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) has welcomed experienced pharmaceutical executive Robert B. Clark to the board of directors as they look to use his senior-level strategic regulatory affairs expertise and more than 38 years of US and global regulatory experience.
Clark is a strong appointment for the clinical-stage pharmaceutical company and his 20-plus years with Pfizer Inc (NYSE:PFE) and 10-plus years with Novo Nordisk (NYSE:NVO) A/S will be invaluable as IHL continues to develop unique medicinal cannabinoid pharmaceutical products and psychedelic therapies for unmet medical needs.
Expertise unlimited
Clark is an internationally recognised expert on US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) liaison interactions, US pharmaceutical advertising practices and regulatory aspects related to healthcare professionals and sales force activities.
He is vice president, US Regulatory Affairs, for Novo Nordisk (NYSE:NVO) where he provides strategic leadership to a team of more than 50 regulatory staff and scientists in the development of new medicines and advises the global executive team on matters related to drug development programs, FDA liaison strategies, managing FDA-related compliance issues, and monitoring emerging US regulatory trends and opportunities.
Importantly for IHL, Clark and his team have secured FDA approvals for 12 significant new drugs for Novo Nordisk since he began with he company in 2012.
Prior to joining Nova Nordisk, Clark was vice president of Worldwide Regulatory Strategy and US Regulatory Affairs at Pfizer, leading a team of up to 150 regional regulatory professionals supporting the drug development continuum.
At Pfizer, Clark led or supported FDA approval of many new medicines and represented the pharma giant at critical interactions with FDA, and other global health authorities, including key project milestone meetings.
Clark will be able to assist IHL with acquisitions, compliance and due diligence having managed regulatory aspects of large-scale pharmaceutical acquisitions at senior levels.
He also has documented success with FDA accelerated approval programs including Fast-Track, Orphan Drug, Breakthrough Therapy Designations, and Priority Reviews, which are areas of interest for Incannex due to the nature of its drug candidate mix.
Prize recruit
“Bob is among the best credentialed regulatory affairs experts in the world, and we’re delighted that he has joined our board of directors because it is a strong vote of confidence in our drug candidates and development strategy”, CEO and managing director of Incannex Joel Latham said.
“He brings to Incannex deep knowledge of the US regulatory environment and decades of experience at the highest level of large pharmaceutical organisations. His experience will be invaluable to us now that our interactions with FDA have become more frequent whilst we pursue our mission to bring cannabinoid and psychedelic pharmacological solutions to patients with unmet medical needs.”
Clark said of his appointment, “I look forward to working with the board and the management team, and I am excited about the broad Incannex portfolio of products to treat patients who have few or no other available treatments. Cannabinoid and psychedelic pharmacotherapies represent a growing area of research and hold the potential to treat various conditions for which effective options are limited.”